Enhanced Telemedicine for Chronic Childhood Diseases

Overseen By Diana J Martinez Castillo

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Heart disease, Mitochondrial disorders, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if an enhanced telemedicine program can further assist children with complex medical conditions who already receive comprehensive care. Researchers will compare the usual care, which includes standard telemedicine, with an enhanced version called the Enhanced Home-Based Telemedicine Program. This program enables doctors to monitor temperature, oxygen levels, heart and lung sounds, and more directly from the child's home. Children who have been hospitalized twice or more in the past year or are at high risk of hospitalization might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity for families to explore innovative care options that could improve their child's health management at home.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Enhanced Home-Based Telemedicine Program is safe for children with medical complexity?

Research has shown that using telemedicine at home for children with complex medical needs is safe and well-liked. In one study, caregivers found the telehealth device easy to use and reported fewer hospital visits, suggesting it might help families manage their child's health from home more effectively.

Another study found telemedicine to be a safe way for patients to receive health care, although some doctors experienced difficulties with setup. Overall, telemedicine has proven to be a practical and safe option for managing care at home.

While these studies focused on complex cases, they indicate that such programs are generally well-accepted and can reduce the need for hospital stays. This suggests that the improved telemedicine approach in this trial should be safe as well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the enhanced home-based telemedicine program for chronic childhood diseases because it offers a more comprehensive approach than conventional telemedicine. Unlike standard care, which often involves basic video consultations, this enhanced program integrates more personalized monitoring and support directly into a child's daily routine. This approach can lead to better management of chronic conditions by providing real-time feedback and tailored interventions. By leveraging advanced technology, this program aims to improve health outcomes and quality of life for children with chronic diseases, making it a promising advancement in pediatric care.

What evidence suggests that the Enhanced Home-Based Telemedicine Program is effective for children with medical complexity?

Research has shown that improved telemedicine programs for children with complex medical needs can enhance their care. In this trial, participants will join one of two groups: one receiving comprehensive care with enhanced telemedicine (ETM) and the other receiving usual comprehensive care with conventional telemedicine. Studies have found that caregivers find using telehealth devices at home both feasible and appreciated. This method has led to fewer hospital visits. Enhanced telemedicine allows doctors to remotely monitor vital signs like temperature and oxygen levels. It also enables them to see and listen to the heart, lungs, skin, and throat using mobile devices, potentially improving health management for children at home. ^{1 3 6 7 8}

Who Is on the Research Team?

Ricardo A Mosquera, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for children with complex chronic diseases who have been hospitalized multiple times or admitted to the ICU at least once in the past year. They should be considered at high risk of future hospitalization without specialized care, but can't participate if they have major heart disease, mitochondrial disorders, active cancer, a DNR order, or are receiving compassionate end-of-life care.

Inclusion Criteria

I've been hospitalized at least twice or admitted to the ICU once in the past year.

Greater than 50 percent estimated risk of hospitalization without our care as judged by the medical director

Exclusion Criteria

Do-Not-Resuscitate (DNR) order

Patients receiving compassionate care

I have a significant heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive comprehensive care augmented with enhanced telemedicine using remote examination devices

24 months

Regular virtual visits using telemedicine devices

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Home-Based Telemedicine Program

Trial Overview The study is testing whether an enhanced telemedicine program (ETM) that includes remote examination devices can improve care for these children when added to comprehensive care (CC). ETM allows doctors to check vital signs and examine patients through mobile devices from home.

How Is the Trial Designed?

Group I: comprehensive care (CC) augmented with enhanced telemedicine (ETM) Experimental Treatment 2 Interventions

Group II: usual CC (with conventional telemedicine) Active Control 1 Intervention

Enhanced Home-Based Telemedicine Program is already approved in United States for the following indications:

Approved in United States as Enhanced Home-Based Telemedicine Program for:

• Comprehensive care for children with medical complexity

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Children and Youth with Special Health Care Needs National Research Network (CYSHC)

Collaborator

Trials

1

Recruited

300+

Published Research Related to This Trial

A telemedicine program successfully connected the Children's National Medical Center in Washington, DC, with the UAE, providing weekly consultations for 48 children with neurodevelopmental disabilities over a period of 16 months.

The program led to improved clinician satisfaction and achievement of therapy goals, demonstrating that telemedicine can effectively support the management of complex conditions like cerebral palsy and autism in underserved regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International telemedicine consultations for neurodevelopmental disabilities. Pearl, PL., Sable, C., Evans, S., et al.[2014]

A telemedicine program initiated in April 1999 provided 130 consultations for 55 children with special health care needs (CSHCN) in a rural area, significantly improving access to subspecialty care and addressing barriers such as long travel times and missed work for appointments.

Satisfaction rates were extremely high, with all parents/guardians rating their telemedicine experience as 'excellent' or 'very good,' and nearly all local providers expressing similar satisfaction, indicating that telemedicine is an effective and well-received alternative to traditional healthcare delivery for these families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using telemedicine to provide pediatric subspecialty care to children with special health care needs in an underserved rural community. Marcin, JP., Ellis, J., Mawis, R., et al.[2022]

Telemedicine for pediatric weight management has shown noninferior clinical efficacy compared to in-person care, meaning it can effectively help children manage their weight just as well as traditional methods.

Patient satisfaction with telehealth services was high, indicating that families appreciate this method of care, although future studies are needed to explore its long-term health outcomes and compliance with more frequent visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Application of Telemedicine to Pediatric Obesity: Lessons from the Past Decade. DeSilva, S., Vaidya, SS.[2021]

The implementation of telemedicine clinics and online education for children with diabetes significantly reduced the average time between medical visits from 149 days to 89 days over two years, improving access to care.

Hospitalizations decreased from an average of 13 per year to 3.5, and emergency department visits dropped from 8 to 2.5, demonstrating that this approach not only improved health outcomes but also saved approximately $27,860 annually.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved access to subspecialist diabetes care by telemedicine: cost savings and care measures in the first two years of the FITE diabetes project. Malasanos, TH., Burlingame, JB., Youngblade, L., et al.[2007]

Telemedicine has been shown to reduce unplanned hospitalizations and healthcare costs for children with medical complexity (CMC), while also increasing caregiver satisfaction, based on an integrative review of 17 studies.

However, the current evidence is limited and does not demonstrate an improvement in the quality of life for CMC and their families, indicating a need for further high-quality research to explore additional health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of telemedicine on health outcomes in children with medical complexity: an integrative review. Ferro, F., Tozzi, AE., Erba, I., et al.[2023]

A randomized controlled trial involving families of children with medical complexity showed that an advanced practice registered nurse (APRN) intervention using telehealth improved the adequacy of care coordination help received over time, indicating its potential effectiveness in addressing unmet needs.

Despite high levels of family-centered care reported at the medical home, families still expressed a need for more care coordination support, highlighting the importance of developing new models to better meet these needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting the needs of children with medical complexity using a telehealth advanced practice registered nurse care coordination model. Cady, RG., Erickson, M., Lunos, S., et al.[2023]

Telemedicine can effectively provide healthcare to children in rural and semi-urban areas of the Indian subcontinent, as demonstrated by a study of 306 patients aged 0-15 years from 2005 to 2008.

The study highlighted that 10% of the children were critically ill and benefited from telemedicine consultations, which could potentially prevent unsafe transportation to healthcare facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of telemedicine for children in India. Singh, M., Das, RR.[2021]

The SUPER project developed a digital platform aimed at improving collaboration and information sharing among families, health services, and schools for children with autism spectrum disorder (ASD), demonstrating its potential to enhance personalized care.

In a preliminary user test with 30 participants, SUPER received an excellent usability score of 89.2, indicating it is a user-friendly tool that can effectively support communication and collaboration in managing ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multidisciplinary Telerehabilitation Approach for Supporting Social Interaction in Autism Spectrum Disorder Families: An Italian Digital Platform in Response to COVID-19. Vallefuoco, E., Purpura, G., Gison, G., et al.[2021]

The telemedicine-based program (TEAM-ED) significantly improved follow-up visits and preventive care actions for children with asthma after an emergency department visit, with 91% of participants attending at least one telemedicine visit.

While TEAM-ED showed better follow-up and preventive medication use, it did not lead to overall improvements in asthma morbidity or medication adherence, highlighting the need for ongoing management support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the Telemedicine Enhanced Asthma Management through the Emergency Department (TEAM-ED) Program on Asthma Morbidity: A Randomized Controlled Trial. Halterman, JS., Fagnano, M., Tremblay, P., et al.[2023]

Parents of children with medical complexity reported high satisfaction with healthcare delivery both before and after the implementation of telehealth services, indicating that telehealth did not negatively impact their experiences.

The school serving children with medical complexity had a significantly higher utilization of telehealth services compared to 12 other schools, suggesting that telehealth is a valuable resource for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing school based telehealth for children with medical complexity. Cormack, CL., Garber, K., Cristaldi, K., et al.[2018]

Post-hospitalization telemedicine video visits (TMVV) for children with medical complexity were found to be feasible, with 82% of patients completing at least one visit and a median connection time of just 1 minute.

Parents reported high acceptability of TMVV, scoring an average of 6.42 on a scale of 1 to 7, indicating that this method of care transition is well-received by families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Post-hospitalization Telemedicine Video Visits for Children With Medical Complexity. Ming, DY., Li, T., Ross, MH., et al.[2022]

Tele-HomeCare (THC) effectively supports children with complex healthcare needs during their transition from hospital to home, showing sustained improvements in health-related quality of life (QoL) for both children and their parents over a 6-week period.

Families using THC experienced similar QoL improvements as those receiving standard care, without additional burdens, indicating that THC is a viable option for managing complex care needs at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An examination of quality of life of children and parents during their Tele-Homecare experience. Young, NL., Bennie, J., Barden, W., et al.[2007]

Parents and caregivers see telemedicine as a valuable tool for pediatric subspecialty care, particularly for previsit assessments and follow-up communication, but prefer it to complement rather than fully replace in-person visits.

Key factors for successful telemedicine implementation include transparent scheduling, same-day options, continuity of care with familiar providers, and clear guidelines on when to use telemedicine, emphasizing the importance of patient and caregiver preferences in designing these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Perspectives on Telemedicine for Pediatric Subspecialty Care. Ray, KN., Ashcraft, LE., Mehrotra, A., et al.[2018]

A pediatric epilepsy telemedicine program, evaluated three years after its implementation, showed high parent satisfaction among 116 families, with 85% of patients having follow-ups longer than 6 months.

Parents reported benefits such as reduced travel time and costs, less missed work or school, improved access to medications, and clear communication about their child's epilepsy, highlighting telemedicine's effectiveness in managing epilepsy care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine and epilepsy: A patient satisfaction survey of a pediatric remote care program. Fortini, S., Espeche, A., Caraballo, R.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6842894/

Home-Based Telemedicine for Children with Medical ... This study demonstrated that use of an in-home telehealth device is feasible, well received by caregivers, and can result in decreased hospitalizations.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03590509

An Integrated Telemedicine-Home Visitation Program to ... Comprehensive care (CC) provided in an enhanced medical home to assure effective care at any hour for or children with medical complexity. What is the study ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30628860/

Home-Based Telemedicine for Children with Medical ... Objective: To evaluate the feasibility, usability, and impact of an in-home telehealth device in the care of CMC.Methods: This single-center feasibility study ...

4. publications.aap.org publications.aap.org/pediatrics/article/148/3/e2021051429/181023/Let-Telemedicine-Enhance-Your-Medical-Home

Let Telemedicine Enhance Your Medical Home | Pediatrics Families were randomly selected to receive comprehensive care (experienced primary care physicians, 24/7 access by phone, same-day illness care ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876285921005313

Use of Telehealth to Enhance Care for Children and Youth ... Intervention research to improve care and outcomes for children with medical complexity and their families. Current Problems in Pediatric and Adolescent ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03590509

An Integrated Telemedicine-Home Visitation Program to ... Children with medical complexity (CMC) account for <1% of all children but approximately 40% of all pediatric deaths and inpatient care spending in the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8013575/

Telemedicine in children with medical complexity on home ... The aim of this article is to describe our experience with telemedicine (teleconsultation [TC] and telemonitoring of ventilator [TM]) in CMC on ventilation.

8. liebertpub.com liebertpub.com/doi/abs/10.1089/tmj.2018.0186?doi=10.1089/tmj.2018.0186

Home-Based Telemedicine for Children with Medical ... Results: Twenty-four patients were enrolled (9 controls, 15 in the intervention group) in September 2016. The telehealth device was attempted in 73 encounters.